ANDA 202588

SANDOZ INC

FDA Drug Application

Application #202588

Application Sponsors

ANDA 202588

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL

500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG

0

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-03-04
LABELING; Labeling	SUPPL	4	AP	2022-03-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-08-18	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	4	Null	7
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202588
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN","activeIngredients":"AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE","strength":"500MG,N\/A,N\/A;N\/A,500MG,N\/A;N\/A,N\/A,30MG","dosageForm":"CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-03-04
        )

)